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Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00384046
Collaborator
(none)
272
Enrollment
31
Locations
2
Arms
8
Duration (Months)
8.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

300mcg/day testosterone

Drug: Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
Placebo Comparator: 2

Placebo arm

Drug: Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks

Outcome Measures

Primary Outcome Measures

  1. To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters. [Assessment at 12 and 24 weeks]

Secondary Outcome Measures

  1. To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires. [Assessment at 12 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.
Exclusion Criteria:
  • Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Facility Ashfield New South Wales Australia 2131
2 Research Facility Gordon New South Wales Australia 2072
3 Research Facility Randwick New South Wales Australia 2031
4 Research Facility Dulwich South Australia Australia 5065
5 Research Facility Prahran Victoria Australia 3181
6 Research Facility Nedlands Western Australia Australia 6009
7 Research Facility Freiburg DEU Botswana D-79085
8 Research Facility Montréal Quebec Canada H1T 1P6
9 Research Facility Quebec City Quebec Canada G1S 2L6
10 Research Facility Aachen Germany D-52074
11 Research Facility Hamburg Germany 20357
12 Research Facility Münster Germany 48149
13 Site Facility Headington Oxford United Kingdom OX3 9DU
14 Research Facility Solihull West Midlands United Kingdom B91 2JL
15 Research Facility Atherstone United Kingdom CV9 1EU
16 Research Facility Coventry United Kingdom CV7 8LA
17 Research Facility Doncaster United Kingdom DN1 2ET
18 Research Facility Headington United Kingdom OX3 9DU
19 Research Facility Herts United Kingdom SG6 4TS
20 Research Facility Leicester United Kingdom LE1 5WW
21 Research Facility Leicester United Kingdom LW1 5WW
22 Research Facility Lichfield United Kingdom WS14 9LH
23 Research Facility London United Kingdom NW8 9NH
24 Research Facility London United Kingdom SE1 9RT
25 Research Facility London United Kingdom SW1W 8RH
26 Research Facility London United Kingdom W12 0HS
27 Research Facility London United Kingdom W1G 7JW
28 Research Facility London United Kingdom W2 1NY
29 Research Facility Plymouth United Kingdom PL4 8QU
30 Research Facility Salford United Kingdom M8 8HD
31 Research Facility Warks United Kingdom CV9 1EU

Sponsors and Collaborators

  • Warner Chilcott

Investigators

  • Study Director: Imran A Lodhi, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00384046
Other Study ID Numbers:
  • 2005108
First Posted:
Oct 4, 2006
Last Update Posted:
Apr 17, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Hypokinesia
Sexual Dysfunctions, Psychological
Testosterone

Study Results

No Results Posted as of Apr 17, 2013